Home / 510(k) Clearances / K251611

510(k) K251611

Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE) by Fisher &Paykel Healthcare , Ltd. — Product Code BTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 2025
Date Received
May 27, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Humidifier, Respiratory Gas, (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5450
Review Panel
AN
Submission Type

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  • K223684 — F&P 820 Humidification System (September 5, 2023)

Other clearances for product code BTT

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  • K251419 — Laboratorios Biogalenic Sterile Water for Inhalation, USP (January 14, 2026)
  • K253479 — Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J) (December 19, 2025)
  • K250312 — Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo (July 2, 2025)
  • K242717 — Laboratorios Biogalenic Sterile Water for Inhalation, USP (January 30, 2025)
  • K241778 — Hudson RCI Comfort Flo® CubCannula™ (December 19, 2024)
  • K240163 — Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula (September 27, 2024)
  • K234058 — F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041 (August 8, 2024)
  • K233707 — HFT150 (June 14, 2024)
  • K233821 — F&P Optiflow Oxygen Kit (AA451J) (June 13, 2024)